A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin In The Treatment Of Postherpetic Neuralgia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- Mean Pain Scores at Endpoint
研究概览
简要总结
The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visual Analogue Scale (VAS) of pain is higher than 40 mm.
- •Pain is sustained for more than 3 months after healing of herpes zoster skin rash.
排除标准
- •Malignancy within the past 2 years.
- •Patients who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia.
- •Creatinine clearance </= 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation, by omitting any decimal fractions).
- •Patients having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia.
- •Skin conditions in the affected dermatome that could alter sensation.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Pregabalin 150mg/day
干预措施: Pregabalin (Drug)
Pregabalin 300mg/day
干预措施: Pregabalin (Drug)
Pregabalin 600mg/day
干预措施: Pregabalin (Drug)
结局指标
主要结局
Mean Pain Scores at Endpoint
时间窗: Week13/discontinuation
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations
时间窗: Week13/discontinuation
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
Number of Responders
时间窗: Week13/discontinuation
A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.
Mean Pain Scores at Week 1
时间窗: Week 1
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 2
时间窗: Week 2
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 3
时间窗: Week 3
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 4
时间窗: Week4
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 5
时间窗: Week 5
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 6
时间窗: Week 6
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 7
时间窗: Week 7
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 8
时间窗: Week 8
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 9
时间窗: Week 9
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 10
时间窗: Week 10
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 11
时间窗: Week 11
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 12
时间窗: Week 12
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Mean Pain Scores at Week 13
时间窗: Week 13
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
次要结局
- Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire(Week13/discontinuation)
- Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire(Week13/discontinuation)
- Endpoint Total Scores of the Short-Form McGill Pain Questionnaire(Week13/discontinuation)
- Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire(Week13/discontinuation)
- Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire(Week13/discontinuation)
- Mean Sleep Interference Scores at Endpoint(Week13/discontinuation)
- Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance(Week13/discontinuation)
- Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring(Week13/discontinuation)
- Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache(Week13/discontinuation)
- Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep(Week13/discontinuation)
- Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy(Week13/discontinuation)
- Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence(Week13/discontinuation)
- Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index(Week13/discontinuation)
- Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep(Week13/discontinuation)
- Endpoint Patient Global Impression Change(Week13/discontinuation)
- Endpoint Clinical Global Impression Change(Week13/discontinuation)
- Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning(Week13/discontinuation)
- Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical(Week13/discontinuation)
- Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain(Week13/discontinuation)
- Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception(Week13/discontinuation)
- Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning(Week13/discontinuation)
- Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional(Week13/discontinuation)
- Endpoint Short-Form 36-Item Health Survey Scores: Vitality(Week13/discontinuation)
- Endpoint Short-Form 36-Item Health Survey Scores: Mental Health(Week13/discontinuation)
- Number of Patients Not Reporting Allodynia(Week13/discontinuation)
- Number of Patients Not Reporting Hyperalgesia(Week13/discontinuation)
- Mean Sleep Interference Scores at Week 1(week 1)
- Mean Sleep Interference Scores at Week 2(week 2)
- Mean Sleep Interference Scores at Week 3(week 3)
- Mean Sleep Interference Scores at Week 4(week 4)
- Mean Sleep Interference Scores at Week 5(week 5)
- Mean Sleep Interference Scores at Week 6(week 6)
- Mean Sleep Interference Scores at Week 7(week 7)
- Mean Sleep Interference Scores at Week 9(week 9)
- Mean Sleep Interference Scores at Week 8(week 8)
- Mean Sleep Interference Scores at Week 10(week 10)
- Mean Sleep Interference Scores at Week 11(week 11)
- Mean Sleep Interference Scores at Week 12(week 12)
- Mean Sleep Interference Scores at Week 13(week 13)